Actively Recruiting
A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension ViTAL-PH
Led by Apollo Therapeutics Ltd · Updated on 2026-05-11
48
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and potential effectiveness of multiple subcutaneous injections of APL-9796 in adults with pulmonary hypertension PH in this phase 2, open-label dose escalation trial. The study focuses on adults diagnosed with WHO Group 1 Pulmonary Arterial Hypertension PAH and optionally includes adults with WHO Group 3 PH associated with interstitial lung disease PH-ILD. The trial also monitors whether the body produces antibodies against APL-9796. The study is conducted in two parts with different participant groups. Part A involves up to 36 adults with WHO Group 1 PAH receiving one of three planned dose levels of APL-9796, evaluated sequentially in cohorts of four participants. An optional Part B may include up to 12 adults with WHO Group 3 PH-ILD, with initiation decided by a Safety Review Committee. The treatment is given as subcutaneous injections, and dose levels are adjusted based on ongoing safety data. Participants will be assessed through various evaluations including telemetry parameters, six-minute walk tests, NT-proBNP blood tests, and quality of life questionnaires from baseline through day 169. Pharmacokinetics and immune response to APL-9796 will be monitored at regular visits approximately every 28 days until day 169, with additional follow-ups on days 254, 339, and 508. The primary outcome focuses on the incidence of treatment-emergent adverse events over about two years, ensuring thorough safety and tolerability monitoring throughout the study.
CONDITIONS
Brief Title
A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 18 and 80 years old inclusive
- Diagnosed with pulmonary hypertension by right heart catheterisation at any time before screening
- WHO Functional Class II or III
- Have a CardioMEMS PA Sensor implanted
You will not qualify if you...
- Hospital admission related to pulmonary hypertension within 3 months prior to screening
- Major surgery within 3 months prior to screening unless fully recovered
- Pulmonary hypertension caused by HIV, portal hypertension, schistosomiasis, or uncorrected congenital heart disease
- History of left-sided heart disease or significant cardiac disease
- History of uncontrolled high blood pressure
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
- Life expectancy less than 12 months as assessed by the investigator
- Diagnosed with cancer within 5 years before enrollment
- Contraindications to required imaging, diagnostic, or sampling procedures
Research Team
S
Sanjay Aggarwal, MD
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